In late 2022, Sara Gutila's treatment-resistant depression became so severe that she was actively considering suicide. The 34-year-old, who grew up in an orphanage, suffered physical violence, sexual abuse and drug use during her childhood, leaving her with psychological scars that threatened her life.
In desperation, her husband scraped together $600 to pay for the first of six intravenous ketamine treatments at Ketamine Clinic Los Angeles, which administers the generic anesthetic for off-label uses such as treating depression. Ta. When Ms. Gutira took her Uber for her 75-mile drive to Los Angeles, it was her first time leaving her home in Llano, California, in two years. The results were immediate, she said.
“The relief I felt after my first treatment was what I thought 'normal' looked like,” she said. “I've never felt so okay, I've never felt so peaceful.”
For-profit ketamine clinics have proliferated in recent years, offering IV treatment for a variety of mental health issues, including obsessive-compulsive disorder, depression, and anxiety. Off-label use of ketamine hydrochloride, a Schedule III drug approved as an anesthetic by the FDA in 1970, was considered radical just a decade ago, but now there are between 500 and 750 ketamine clinics nationwide. It has been established.
Market research firm Grand View Research predicts industry revenue of $3.1 billion in 2022, more than doubling to $6.9 billion by 2030. Most insurance policies do not cover ketamine for mental health, so patients must pay out-of-pocket.
Although it is legal for doctors to prescribe ketamine, the FDA has not approved it as a mental health treatment, so individual practitioners must develop their own treatment protocols. Results vary widely among health care providers, with some favoring progressively lower doses of treatment and others favoring high-dose treatments that, at appropriate doses, can cause hallucinations.
“Ketamine is the Wild West,” said Dustin Robinson, managing principal at Iter Investments, a venture capital firm that specializes in psychedelic drug treatments.
Ketamine practitioners stress that the drug's emergence as a mental health treatment was driven by a dire need. According to the National Institute of Mental Health, depression is the leading cause of disability among 15- to 44-year-olds in the United States, and approximately 25 percent of adults experience a diagnosable mental disorder each year.
Meanwhile, many insurance plans cover mental health services at lower rates than physical care, despite legal equality requirements. As a result, many patients with the disorder receive little or no care initially, and by the time they arrive at a ketamine clinic, they are in a hopeless situation, says Dr. said Stephen Siegel, dean of behavioral sciences.
However, the revelation that “Friends” star Matthew Perry died in part due to an overdose of ketamine, as well as billionaire Elon Musk's public use of ketamine, has led to widespread criticism of ketamine and its regulatory environment, or lack thereof. New scrutiny has been triggered.
Commercial ketamine clinics often offer same-day appointments, allowing patients to pay out-of-pocket for the drug, which provides immediate results. Ketamine is administered intravenously, and patients are often given blankets, headphones, and eye masks to enhance the dissociative feeling of not being in their own body. A typical dose of ketamine to treat depression is one-tenth of the dose used in anesthesia and costs about $1 in the clinic, but in the clinic it costs $600 to $1,000 per treatment. costs.
Ketamine still suffers from its reputation as a party drug known as “Special K.” Siegel's first grant from the National Institutes of Health was to study ketamine as a drug of abuse. It can send users into a “K-hole” known as a bad trip and can induce psychosis. Studies in animals and recreational users have shown that chronic use of this drug impairs both short- and long-term cognition.
Perry's death in October raised alarm after initial toxicology tests attributed his death to the acute effects of ketamine. A December report said Perry had been receiving IV therapy a week before her death, but that it was the high dose of the substance she ingested on the day of her death, along with opioids and sedatives, that caused her fatal injuries. It was revealed that medical ketamine was not to blame.
various protocols
Sam Mandel co-founded Ketamine Clinic Los Angeles in 2014 with his father, Stephen Mandel, an anesthesiologist with a background in clinical psychology, and says the clinic has established its own protocols. Sam said. This includes monitoring patients' vital signs during treatment and having a psychiatrist or other mental health professional on hand to ensure safety. Initial treatment begins with a low dose and increases as needed.
While many clinics follow the Mandels' step-by-step approach, the dosing protocol at MY Self Wellness, a ketamine clinic in Bonita Springs, Florida, is aimed at inducing a psychedelic episode.
Christina Thomas, president of MY Self Wellness, said she based her clinic's protocols on a list of “don'ts” based on bad experiences reported at other clinics.
This field is not completely unregulated. State medical boards and boards of nursing oversee doctors and nurses, and the FDA and Drug Enforcement Administration regulate ketamine. However, most anesthesiologists have no knowledge of mental health, and psychiatrists do not know much about anesthesia, Sam Mandel points out. He said a collaborative, multidisciplinary approach is needed to develop standards across the field, especially since ketamine can affect vital signs such as blood pressure and breathing.
The protocol governing Spravato, an FDA-approved drug based on a close chemical relative of ketamine called esketamine, is illustrative. Because of the potential for serious side effects, it is subject to the FDA's Risk Evaluation and Mitigation Strategies Program, which has additional requirements, Robinson said. Spravato's REMS requires him to be monitored for two hours after each dose and prohibits patients from driving on treatment days.
In contrast, generic ketamine has no REMS requirements. And because it's generic and cheap, drug companies have little financial incentive to conduct the expensive clinical trials required for FDA approval.
This means it is up to the patient to evaluate their ketamine provider. Clinics that specialize in intravenous infusions, rather than offering the treatment as an add-on, may be more familiar with the nuances of administering the drug. Ideally, the practitioner should have expertise in mental health and anesthesia, or have multiple specialties under the same roof, and the clinic is equipped with hospital-grade monitoring equipment. There is a need, Mandel said.
emergency intervention
Siegel, who has been researching ketamine since 2003, said the drug is particularly useful as an emergency intervention, allowing time long enough for traditional treatments such as talk therapy and SSRI antidepressants to take effect. He said that it can suppress suicidal thoughts. “The solutions we've had so far have been failures,” Mandel said.
The drug is now popular enough as a mental health treatment that 26 Adopt-A-Highway signs along Route 405 and Route 10 bear Mandel's clinic's name and are used by thousands of Angelenos. I see that name every day.
And a psychedelic renaissance in mental health is accelerating. A drug containing MDMA, known as ecstasy or Molly, is expected to receive FDA approval in 2024. A drug containing psilocybin, the active ingredient in magic mushrooms, could be released as early as 2027, and a stroke treatment containing the active ingredient could also be released in the same year. It is expected that ingredients from the hallucinogen DMT will appear.
Robinson said many ketamine clinics are opening in anticipation of a growing psychedelic market. Because these new drugs are more likely to be covered by insurance, Robinson advises clinics to offer FDA-approved treatments such as Spravat so they can have the appropriate insurance infrastructure and staff in place.
For now, Sara Gutila plans to pay for her ketamine treatment out of pocket. A year after her first infusion, she and her husband are saving up for her second infusion. In the meantime, she rescues dogs and horses on her ranch in Llano and relies on telehealth therapy and psychiatric medication to get by.
The IV is not a “magic solution,” but it is a tool to help keep her moving in the right direction.
“Before, there was no light at the end of the tunnel,” she says. “Ketamine literally saved my life.”
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